Trial reportArthritis & rheumatology (Hoboken, N.J.)2022
Tofacitinib and Risk of Malignancy: Results From the Safety of Tofacitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA) Study.
Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed, 4 syntheses or guidelines pooled it, 74 citations in OpenAlex.
- Concordance between target trial emulation and randomised controlled trials: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2026Pooled it
- Comparison of cancer risks associated with JAK inhibitors and TNF inhibitors treatment in patients with rheumatoid arthritis: a systematic review and meta-analysis of real-world cohort studies.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026Pooled it
- Comparative Safety of JAK Inhibitors vs TNF Antagonists in Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis.JAMA network open · 2025Pooled it
- Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials: A Systematic Review.JAMA network open · 2023Pooled it
- Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial.Annals of the rheumatic diseases · 2023Trial
- Tofacitinib and Risk of Malignancy: Results From the Safety of Tofacitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA) Study.Arthritis & rheumatology (Hoboken, N.J.) · 2022Trial
- Article
- Comparative Safety Analysis of Targeted Synthetic and Biologic Disease-Modifying Antirheumatic Drugs Among Patients With Rheumatoid Arthritis: A Nationwide Cohort Study in Japan.International journal of rheumatic diseases · 2026Article
- Does acute inflammation triggered by infection promote cancer progression?PLoS biology · 2026Review
- Safety of Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis: A Longitudinal Analysis.Drug safety · 2026Article
- Design and Implementation of Observational Studies Emulating a Target Trial.JAMA network open · 2026Article
- [New results from the RABBIT register on the cancer risk of patients with rheumatoid arthritis treated with Janus kinase inhibitors].Zeitschrift fur Rheumatologie · 2026Article
- From concept to practice: real-world safety of JAK inhibitors in rheumatoid arthritis treatment.Frontiers in medicine · 2026Review
- Tumor safety of biologic agents and targeted therapies in immune-mediated inflammatory arthritides.Frontiers in immunology · 2026Review
- Immunosuppressants/Immunomodulators and Malignancy.Journal of clinical medicine · 2025Review
- Cancer risk of Janus kinase inhibitors and biological disease-modifying antirheumatic drugs among older Americans with rheumatoid arthritis.Rheumatology (Oxford, England) · 2025Article
- Assessing the replicability of RCTs in RWE emulations.BMC medical research methodology · 2025Article
- Management of Late-Onset Rheumatoid Arthritis with Treat-to-Target Strategy.Drugs & aging · 2025Review
- Safety of Immunosuppression in a Prospective Cohort of Inflammatory Bowel Disease Patients With a HIstoRy of CancEr: SAPPHIRE Registry.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025Article
- Cancer Risk in IBD Patients Treated with JAK Inhibitors: Reassuring Evidence from Trials and Real-World Data.Cancers · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
Abstract
objectivesResults of the ORAL Surveillance safety trial have indicated that there is an increased risk for the development of malignancies with tofacitinib therapy when compared to treatment with tumor necrosis factor inhibitors (TNFi). This study was undertaken to further examine this safety concern in rheumatoid arthritis (RA) patients in a real-world setting.
methodsUsing US insurance claims data from Optum Clinformatics (2012-2020), IBM MarketScan Research Databases (2012-2018), and Medicare (parts A, B, and D, 2012-2017), we created 2 cohorts of RA patients who had initiated treatment with tofacitinib or TNFi. The first cohort, designated the real-world evidence (RWE) cohort, included RA patients from routine care. For the second cohort, designated the randomized controlled trial (RCT)-duplicate cohort, we emulated the inclusion and exclusion criteria that were applied in the ORAL Surveillance trial of tofacitinib, which allowed us to assess the comparability of our results with the results of that trial. Cox proportional hazards models with propensity score fine-stratification weighting were used to estimate hazard ratios (HRs) and 95% confidence intervals (95% CIs) for the risk of any malignancy (excluding nonmelanoma skin cancer). Database-specific estimates were meta-analyzed using fixed-effects models with inverse-variance weighting.
resultsThe RWE cohort consisted of 83,295 patients, including 10,504 patients (12.6%) who received treatment with tofacitinib. The pooled weighted HR for the primary outcome of any malignancy associated with tofacitinib treatment compared to any malignancy associated with TNFi therapy was 1.01 (95% CI 0.83, 1.22) in the RWE cohort and 1.17 (95% CI 0.85, 1.62) in the RCT-duplicate cohort (compared to the ORAL Surveillance trial HR of 1.48 [95% CI 1.04, 2.09]).
conclusionWe did not find evidence of an increased risk of malignancy development with tofacitinib therapy, in comparison with TNFi therapy, in RA patients treated in a real-world setting. However, our results cannot rule out the possibility of an increase in risk that may accrue with a longer duration of treatment with tofacitinib.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.